Trial Outcomes & Findings for Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs (NCT NCT01068652)
NCT ID: NCT01068652
Last Updated: 2017-01-13
Results Overview
Estimated mean difference in HbA1c after 50 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
403 participants
Primary outcome timeframe
Week 50
Results posted on
2017-01-13
Participant Flow
The trial was conducted at 23 sites in 4 countries: Egypt (1), Algeria (9), Tunisia (4) and South Africa (9). The trial consisted of two weeks of screening, three weeks of run-in, and 50 weeks of treatment.
Participant milestones
| Measure |
Detemir + Met
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
203
|
|
Overall Study
COMPLETED
|
182
|
188
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
| Measure |
Detemir + Met
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
3
|
6
|
|
Overall Study
Withdrawal criteria
|
1
|
2
|
|
Overall Study
Patient was not eligible
|
1
|
0
|
|
Overall Study
Unclassified
|
7
|
4
|
Baseline Characteristics
Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs
Baseline characteristics by cohort
| Measure |
Detemir + Met
n=200 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Gender
Female
|
113 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Gender
Male
|
87 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 participants
n=5 Participants
|
58 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
112 participants
n=5 Participants
|
113 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.6 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=7 Participants
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 50Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.
Estimated mean difference in HbA1c after 50 weeks of treatment
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Glycosylated Haemoglobin (HbA1c)
|
7.34 percentage of glycosylated haemoglobin
Standard Error 0.13
|
7.23 percentage of glycosylated haemoglobin
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 0, Week 14Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.
Observed mean change from baseline in HbA1c at Week 14 (visit 11)
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
|
-0.18 percentage of glycosylated haemoglobin
Standard Deviation 1.16
|
-0.64 percentage of glycosylated haemoglobin
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.
Observed mean change in from baseline in HbA1c at Week 26 (visit 18)
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
|
-1.05 percentage of glycosylated haemoglobin
Standard Deviation 1.05
|
-1.30 percentage of glycosylated haemoglobin
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Week 0, Week 38Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.
Observed mean change from baseline in HbA1c at Week 38 (visit 25)
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
|
-1.35 percentage of glycosylated haemoglobin
Standard Deviation 1.16
|
-1.56 percentage of glycosylated haemoglobin
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Week 0, Week 50Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.
Observed mean change from baseline in HbA1c at Week 50 (visit 32)
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
|
-1.16 percentage of glycosylated haemoglobin
Standard Deviation 1.33
|
-1.34 percentage of glycosylated haemoglobin
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Week 14Population: Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing.
Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)
Outcome measures
| Measure |
Detemir + Met
n=191 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
|
15 Subjects
|
26 Subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing.
Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)
Outcome measures
| Measure |
Detemir + Met
n=185 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=189 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
|
67 Subjects
|
77 Subjects
|
SECONDARY outcome
Timeframe: Week 38Population: Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing.
Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)
Outcome measures
| Measure |
Detemir + Met
n=184 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=188 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
|
84 Subjects
|
103 Subjects
|
SECONDARY outcome
Timeframe: Week 50Population: Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing.
Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)
Outcome measures
| Measure |
Detemir + Met
n=181 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=187 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
|
73 Subjects
|
84 Subjects
|
SECONDARY outcome
Timeframe: Week 14Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations.
Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Outcome measures
| Measure |
Detemir + Met
n=188 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=187 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
|
43.19 mg/dL
Standard Deviation 33.64
|
32.61 mg/dL
Standard Deviation 31.99
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.
Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Outcome measures
| Measure |
Detemir + Met
n=192 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
|
32.95 mg/dL
Standard Deviation 30.25
|
31.71 mg/dL
Standard Deviation 27.86
|
SECONDARY outcome
Timeframe: Week 38Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.
Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Outcome measures
| Measure |
Detemir + Met
n=192 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
|
25.44 mg/dL
Standard Deviation 27.95
|
28.32 mg/dL
Standard Deviation 30.69
|
SECONDARY outcome
Timeframe: Week 50Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.
Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Outcome measures
| Measure |
Detemir + Met
n=192 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=192 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
|
22.45 mg/dL
Standard Deviation 25.50
|
23.66 mg/dL
Standard Deviation 28.91
|
SECONDARY outcome
Timeframe: Week 14Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)
Outcome measures
| Measure |
Detemir + Met
n=200 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Before Breakfast (n=193, 194)
|
136.44 mg/dL
Standard Deviation 42.86
|
128.31 mg/dL
Standard Deviation 33.58
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
120 min After Breakfast (n=187, 184)
|
181.89 mg/dL
Standard Deviation 54.42
|
176.31 mg/dL
Standard Deviation 44.50
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Before Lunch (n=192, 193)
|
157.61 mg/dL
Standard Deviation 53.43
|
156.12 mg/dL
Standard Deviation 51.57
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
120 min After Lunch (n=186, 185)
|
199.40 mg/dL
Standard Deviation 64.38
|
199.75 mg/dL
Standard Deviation 59.04
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Before Dinner (n=191, 192)
|
169.69 mg/dL
Standard Deviation 54.91
|
168.09 mg/dL
Standard Deviation 59.58
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
120 min After Dinner (n=183, 185)
|
212.23 mg/dL
Standard Deviation 61.45
|
173.95 mg/dL
Standard Deviation 54.86
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Bedtime (n=187, 192)
|
200.15 mg/dL
Standard Deviation 60.83
|
156.65 mg/dL
Standard Deviation 50.65
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
At 2 AM - 3 AM (n=172, 177)
|
158.69 mg/dL
Standard Deviation 50.06
|
139.93 mg/dL
Standard Deviation 43.39
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)
Outcome measures
| Measure |
Detemir + Met
n=200 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
At 2 AM - 3 AM (n=181, 187)
|
133.59 mg/dL
Standard Deviation 47.54
|
123.29 mg/dL
Standard Deviation 35.16
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Before Breakfast (n=193, 194)
|
116.57 mg/dL
Standard Deviation 34.40
|
115.79 mg/dL
Standard Deviation 27.23
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
120 min After Breakfast (n=191, 191)
|
163.52 mg/dL
Standard Deviation 50.02
|
153.85 mg/dL
Standard Deviation 42.68
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Before Lunch (n=193, 194)
|
140.97 mg/dL
Standard Deviation 49.96
|
131.27 mg/dL
Standard Deviation 42.85
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
120 min After Lunch (n=191, 191)
|
166.00 mg/dL
Standard Deviation 57.15
|
178.92 mg/dL
Standard Deviation 51.14
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Before Dinner (n=192, 194)
|
147.58 mg/dL
Standard Deviation 48.90
|
143.29 mg/dL
Standard Deviation 45.50
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
120 min After Dinner (n=188, 191)
|
172.21 mg/dL
Standard Deviation 57.34
|
152.44 mg/dL
Standard Deviation 45.53
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Bedtime (n=190, 194)
|
164.70 mg/dL
Standard Deviation 63.68
|
140.39 mg/dL
Standard Deviation 42.71
|
SECONDARY outcome
Timeframe: Week 38Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)
Outcome measures
| Measure |
Detemir + Met
n=200 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Before Dinner (n=193, 194)
|
132.26 mg/dL
Standard Deviation 41.90
|
129.10 mg/dL
Standard Deviation 43.84
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
120 min After Lunch (n=191, 192)
|
145.91 mg/dL
Standard Deviation 51.38
|
158.45 mg/dL
Standard Deviation 47.70
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Before Breakfast (n=193, 194)
|
110.14 mg/dL
Standard Deviation 30.64
|
110.86 mg/dL
Standard Deviation 27.11
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
120 min After Breakfast (n=191, 192)
|
146.70 mg/dL
Standard Deviation 44.11
|
139.38 mg/dL
Standard Deviation 42.74
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Before Lunch (n=193, 194)
|
130.63 mg/dL
Standard Deviation 42.17
|
118.30 mg/dL
Standard Deviation 40.28
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
120 min After Dinner (n=192,192)
|
155.47 mg/dL
Standard Deviation 49.09
|
142.82 mg/dL
Standard Deviation 50.47
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Bedtime (n=193, 194)
|
146.37 mg/dL
Standard Deviation 51.58
|
132.45 mg/dL
Standard Deviation 43.54
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
At 2 AM - 3 AM (n=187, 190)
|
124.57 mg/dL
Standard Deviation 42.11
|
117.42 mg/dL
Standard Deviation 35.60
|
SECONDARY outcome
Timeframe: Week 50Population: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)
Outcome measures
| Measure |
Detemir + Met
n=200 Participants
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 Participants
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Before Breakfast (n=193, 194)
|
108.78 mg/dL
Standard Deviation 31.10
|
110.76 mg/dL
Standard Deviation 22.08
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
120 min After Breakfast (n=191, 192)
|
140.05 mg/dL
Standard Deviation 40.98
|
132.45 mg/dL
Standard Deviation 35.55
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Before Lunch (n=193, 194)
|
120.43 mg/dL
Standard Deviation 37.62
|
115.02 mg/dL
Standard Deviation 36.20
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
120 min After Lunch (n=191, 192)
|
139.48 mg/dL
Standard Deviation 49.03
|
149.90 mg/dL
Standard Deviation 44.32
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Before Dinner (n=193, 194)
|
128.28 mg/dL
Standard Deviation 40.63
|
126.76 mg/dL
Standard Deviation 40.16
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
120 min After Dinner (n=192, 192)
|
144.19 mg/dL
Standard Deviation 49.24
|
138.08 mg/dL
Standard Deviation 42.11
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Bedtime (n=193, 194)
|
137.13 mg/dL
Standard Deviation 51.18
|
130.10 mg/dL
Standard Deviation 43.08
|
|
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
At 2 AM - 3 AM (n=187, 190)
|
118.60 mg/dL
Standard Deviation 40.65
|
113.14 mg/dL
Standard Deviation 35.21
|
Adverse Events
Detemir + Met
Serious events: 13 serious events
Other events: 75 other events
Deaths: 0 deaths
BIAsp 30 + Met
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Detemir + Met
n=200 participants at risk
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 participants at risk
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.99%
2/203 • Number of events 2 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Infections and infestations
Bronchitis
|
1.0%
2/200 • Number of events 2 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Infections and infestations
Cellulitis
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Infections and infestations
Pneumonia
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Investigations
Weight decreased
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Psychiatric disorders
Depression
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/200 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.00%
0/203 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/200 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
0.49%
1/203 • Number of events 1 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
Other adverse events
| Measure |
Detemir + Met
n=200 participants at risk
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.
|
BIAsp 30 + Met
n=203 participants at risk
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
16/200 • Number of events 17 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
5.4%
11/203 • Number of events 11 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
13/200 • Number of events 15 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
7.4%
15/203 • Number of events 20 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Infections and infestations
Influenza
|
7.5%
15/200 • Number of events 20 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
8.4%
17/203 • Number of events 20 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Infections and infestations
Urinary tract infection
|
5.0%
10/200 • Number of events 11 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
5.4%
11/203 • Number of events 13 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Nervous system disorders
Headache
|
6.5%
13/200 • Number of events 18 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
5.9%
12/203 • Number of events 12 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Vascular disorders
Hypertension
|
4.0%
8/200 • Number of events 8 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
5.9%
12/203 • Number of events 14 • The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER